(87 days)
Not Found
No
The description focuses on data management, storage, networking, and basic editing functionalities of digitized ECG records. There is no mention of algorithms that learn from data or perform complex pattern recognition beyond what would be expected in a standard data management system of that era (Pentium™ computer, LaserJet printer). The "interpretation performed by the electrocardiograph" is mentioned, but this interpretation is likely generated by the separate electrocardiograph device, not the TraceMaster system itself, and there's no indication this interpretation uses AI/ML.
No
This device is a data management system for ECG records, allowing for viewing, editing, printing, and archiving. It does not directly provide therapy or interact with the patient for therapeutic purposes.
No
The device processes and stores existing ECG records from another device. It does not generate new diagnostic information itself, but rather allows for viewing, editing, and archiving of data already acquired by an electrocardiograph machine. While it facilitates the review of diagnostic information, it is not the source of the diagnosis.
No
The device description explicitly mentions hardware components like a "high-performance Pentium™ computer," "high-speed, online disks," and a "HP LaserJet printer." It also describes connections via "Local Area Network or floppy diskettes" and "modem," indicating a system that includes more than just software. The performance studies also include electromagnetic immunity and emissions testing, which are typically performed on hardware.
Based on the provided information, the M1730B TraceMaster ECG System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The M1730B TraceMaster ECG System processes and manages digitized electrocardiograph records. These records are generated by electrocardiograph machines, which measure the electrical activity of the heart in vivo (within the living body), not in vitro (in a test tube or lab setting).
- Intended Use: The intended use clearly states it allows "viewing, manual editing, printing, and archiving of digitized electrocardiograph records." This is a data management and processing function for in vivo generated data.
- Lack of Biological Sample Handling: The description does not mention any handling or analysis of biological samples.
Therefore, the M1730B TraceMaster ECG System is a medical device used for managing and processing data from an in vivo diagnostic procedure (ECG), but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
The M1730B TraceMaster ECG System is a computer system which allows viewing, manual editing, printing and archiving of digitized electrocardiograph records from from Hewlett-Packard Company electrocardiograph machines.
Product codes
74 DSH
Device Description
The HP M1730B TraceMaster is an advanced data management system that automates the processing and storage of ECGs from HP PageWriter cardiographs. Its high-performance Pentium™ computer stores up to 750,000 ECGs on high-speed, online disks and produces clean, permanent traces on a HP LaserJet printer. The multitasking operating system smoothly handles the rigorous demands of simultaneous editing, printing, reception, and storage of ECGs. A powerful client/server network can spread the workload of editing, transmitting, and printing to M1776B Local Edit Stations, LAN-connected HP LaserJet printers, and M1798B Remote Edit Stations.
Electrocardiograms can be transferred from HP electrocardiographs to the TraceMaster via the Local Area Network or floppy diskettes. On the Edit Stations users can then view the ECG and the interpretation performed by the electrocardiograph, compare to previous waveforms and interpretations, and overread and edit the interpretation. Remote Edit Stations can be connected via the Local Area Network or modem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests Used in Determination of Substantial Equivalence: The M1730B TraceMaster ECG System was tested for Electromagnetic Immunity tests included IEC 801-2, IEC 801-3, and Compatibility. IEC801-4. Emissions were tested to measure the emission of radio-frequency Eimssions were "tested" to "meaber" and the mains in accordance with CISPR22:1993, class A. The essential functions of the M1730B TraceMaster ECG System have been I he essential functions of the M17562 Fraces and was found to meet all requirements specifications. Conclusions From Nonclinical Testing: The testing of the M1730B TraceMaster ECG System demonstrates that the The testing of the NFT 50D Tracemance is a subset of the features in the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
510(k) Summary for M1730B TraceMaster ECG System
FEB 1 9 1998
- Date this summary was prepared: November 20, 1997 1.
- Submitter's Name and Address
Hewlett-Packard Company 3000 Minuteman Road Andover, MA 01810-1099
- Contact Person 3.
Mr. George Diller
| Telephone | (978)659-4971 |
|---|---|
| Telefax | (978)659-3168 |
-
- Device Name
M1730B TraceMaster ECG System Proprietary Name: M1766B Local Edit Station M1798B Remote Edit Station
- Device Name
ECG Management System Common Name:
Classification Name: unknown
-
- Predicate Devices
The legally marketed device to which equivalence is being claimed is the Muse 5000 System manufactured by Marquette Electronics, Inc. (K840932). The design of TraceMaster is substantially equivalent in safety and performance to a subset of the Muse 5000 features, with the important exception that TraceMaster does not perform any computerized interpretation of the ECG waveform.
- Predicate Devices
1
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- Device Description
The HP M1730B TraceMaster is an advanced data management system that automates the processing and storage of ECGs from HP PageWriter cardiographs. Its high-performance Pentium™ computer stores up to 750,000 ECGs on high-speed, online disks and produces clean, permanent traces on a HP LaserJet printer. The multitasking operating system smoothly handles the rigorous demands of simultaneous editing, printing, reception, and storage of ECGs. A powerful client/server network can spread the workload of editing, transmitting, and printing to M1776B Local Edit Stations, LAN-connected HP LaserJet printers, and M1798B Remote Edit Stations.
- Device Description
Electrocardiograms can be transferred from HP electrocardiographs to the TraceMaster via the Local Area Network or floppy diskettes. On the Edit Stations users can then view the ECG and the interpretation performed by the electrocardiograph, compare to previous waveforms and interpretations, and overread and edit the interpretation. Remote Edit Stations can be connected via the Local Area Network or modem.
-
- Intended Use
The M1730B TraceMaster ECG System is a computer system which allows viewing, manual editing, printing and archiving of digitized electrocardiograph records from from Hewlett-Packard Company electrocardiograph machines.
- Intended Use
Comparison of Technological Characteristics 8.
The M1730B TraceMaster ECG System and the Muse 5000 both are PC bases systems utilizing commercial operating systems and networking software. They have similar geometry and construction.
The TraceMaster can handle a throughput of up to 56,000 ECGs per year, while the Muse 5000 can handle at least 30,000. The TraceMaster can store 750,000 ECGs on-line, while the Muse 5000 can store up to 1.1 million. Both offer viewing and editing on a video screen, hard copy printouts, and connection to the electrocardiograph via direct connect, removable diskette, or modem. Both systems feature a serial comparison function which shows waveform differences between successive ECGs.
An important difference is that TraceMaster does not perform any computerized interpretation of the ECG waveform.
2
- Nonclinical Tests Used in Determination of Substantial Equivalence 9.
The M1730B TraceMaster ECG System was tested for Electromagnetic Immunity tests included IEC 801-2, IEC 801-3, and Compatibility. IEC801-4.
Emissions were tested to measure the emission of radio-frequency Eimssions were "tested" to "meaber" and the mains in accordance with CISPR22:1993, class A.
The essential functions of the M1730B TraceMaster ECG System have been I he essential functions of the M17562 Fraces and was found to meet all requirements specifications.
- Conclusions From Nonclinical Testing 10.
The testing of the M1730B TraceMaster ECG System demonstrates that the The testing of the NFT 50D Tracemance is a subset of the features in the predicate device.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
FEB 1 9 1998
Mr. Steven A. Clarke Staff Consultant Medical Device Consultants, Inc. 49 Plain Street 02760 North Attleboro, MA
K974420 Re: M1730 TraceMaster ECG System Trade Name: Regulatory Class: II (two) Product Code: 74 DSH Dated: November 20, 1997 November 24, 1997 Received:
Dear Mr. Clarke:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through-periodic GMP ------inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements requlatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. Steven A. Clarke
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callaha Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1 __
510(k) Number:__K974420
Device Name: Mi730 TraceMaster ECG Systeml
Indications For Use:
The M1730B TraceMaster ECG System is a computer system which allows viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Hewlett-Packard company electrocardiograph machines.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER: PAGE IF ------------------------------------------------------------------------------------------------------------NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for PBT
(Divjsion Sign-Off) / Division of Cardiovascular, Respiratory, and Neurological Devices K974420 510(k) Number.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)